Benalmadena

Researchers are evaluating the efficacy and safety of benralizumab, given as a subcutaneous injection, in children and adolescents aged 6 to under 18 years who have severe eosinophilic asthma. These patients have a history of asthma exacerbations and uncontrolled symptoms despite treatment with high-dose inhaled corticosteroids plus at least one other controller medication. This Phase III study aims to compare benralizumab to placebo in reducing the time to the first asthma exacerbation. The study includes a screening period lasting from 4 to 12 weeks to confirm eligibility. After screening, patients are randomly assigned in a 1:1 ratio to receive either benralizumab or placebo via subcutaneous injections during a double-blind treatment period lasting a minimum of 16 weeks. This period continues until the patient experiences an asthma exacerbation or a set number of events occur. Patients who exacerbate can enter an open-label extension where all receive benralizumab for at least 48 weeks. An end-of-treatment visit occurs 8 weeks after the last dose in the extension phase. Participants will be monitored through visits and assessments including confirmation of severe eosinophilic asthma, asthma control questionnaires, and symptom diaries. Researchers will measure the time to first asthma exacerbation as the primary outcome. Medication adherence is tracked during screening, and safety is monitored throughout both the double-blind and extension periods. Total participation may span over a year, considering screening, treatment, extension, and follow-up visits.

Researchers are evaluating the efficacy and safety of verekitug (UPB-101) in adults with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), a long-term inflammatory lung condition. This global, multicenter Phase 2b study aims to understand how well verekitug works compared to a placebo, alongside participants' usual COPD medications. Participants must have a confirmed COPD diagnosis and meet specific lung function and symptom criteria to join the study. Participants will be randomly assigned to receive one of two doses of verekitug or a matching placebo, in addition to their regular COPD background treatments. The study includes a screening period of about 4 weeks, followed by treatment lasting between 60 and 108 weeks. After treatment, there is a 16-week follow-up period to monitor participants after their last dose. Throughout the study, participants will undergo various assessments including lung function tests and symptom evaluations. Researchers will track the annual rate of moderate or severe COPD flare-ups from the start of treatment through week 108. Safety and tolerability will be closely monitored during the treatment and follow-up periods to ensure participants' well-being over the course of the trial.

Researchers are studying AZD0292, a bispecific antibody, to see if it can prevent flare-ups in people aged 12 and older who have bronchiectasis with chronic colonization by Pseudomonas aeruginosa (PsA). This Phase IIb trial compares two different doses of AZD0292 given through intravenous infusion against a placebo. The study mainly focuses on non-cystic fibrosis bronchiectasis patients with frequent PsA-related lung exacerbations, which can worsen lung function, quality of life, and survival. Cystic fibrosis bronchiectasis patients colonized with PsA are also included as an exploratory group. Participants will receive either a high or low dose of AZD0292 or a placebo starting on Day 1 by IV infusion, with additional doses given according to the study schedule. The trial is randomized, double-blind, placebo-controlled, and parallel in design. Treatment effects, safety, and how the body processes the drug will be studied over the course of dosing. During the study, participants will be monitored for lung exacerbations over a follow-up period ranging from 28 to 52 weeks. Researchers will assess lung function, collect airway samples to confirm PsA colonization, and track any side effects or adverse events. The main measure of success is the annualized rate of exacerbations. Participants must adhere to study visits and assessments throughout the trial to help determine the drug’s effectiveness and safety.

Researchers are evaluating the effects and safety of AZD6793 tablets in adults aged 40 years and older who have moderate to very severe chronic obstructive pulmonary disease (COPD). This is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled study involving approximately 1160 participants at around 400 sites worldwide. The study aims to compare three different doses of AZD6793 against placebo tablets over 24 weeks to assess how well the treatment works and its safety profile in this population. Participants will be randomly assigned to one of four groups receiving either one of three doses of AZD6793 or a placebo in equal proportions. The treatment involves oral administration of AZD6793 tablets or placebo tablets daily for 24 weeks. The study is designed with parallel groups and includes careful dose-ranging to evaluate different levels of the investigational drug. During the study, participants will be monitored for the annualized rate of moderate or severe COPD exacerbations from baseline up to 24 weeks. Assessments include lung function tests such as pre- and post-bronchodilator FEV1/FVC ratios, symptom questionnaires like the COPD Assessment Test (CAT), and documentation of COPD exacerbation history. Safety will be continually evaluated through clinical assessments and laboratory tests throughout the treatment period.

The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.

Asthma is a chronic lung condition marked by inflammation that narrows and swells the airways, causing symptoms that can change and worsen unpredictably. This research aims to evaluate how depemokimab, a monoclonal antibody, impacts lung structure and function in people with asthma characterized by type 2 inflammation and an eosinophilic phenotype. The study is a Phase 3b open-label, single-arm trial designed to gather detailed imaging and bronchoscopic samples to better understand these effects. Participants will receive depemokimab as the investigational treatment. The study involves advanced imaging techniques using quantitative high-resolution CT scans and bronchoscopic airway sampling to assess changes in the lungs. The bronchoscopy sub-study has additional criteria and procedures focused on biopsy and airway sampling. Depemokimab will be administered during the trial according to the study plan. Participants will be monitored through multiple assessments including lung function tests, blood tests for eosinophil counts, exhaled nitric oxide levels, and questionnaires about asthma control. The main measurement is the change in total mucus plug volume in the lungs at week 26 compared to baseline. Safety and adherence will be carefully tracked, and participants who consent to the bronchoscopy sub-study will undergo additional procedures. Overall involvement includes regular visits and evaluations to observe lung structure and function changes over the study period.

Researchers are evaluating whether taking the Ovosicare4 Fertility food supplement can increase the chance of becoming pregnant in women aged 32 to 38 years who have been trying to conceive for at least six months. This observational study focuses on fertility and aims to understand the supplement's impact on spontaneous pregnancy rates within this age group. Participants will take the Ovosicare4 Fertility supplement, which contains a combination of MYO/DCI in a 3.6:1 ratio, antioxidants, vitamins, and minerals. The study does not involve extra tests or visits beyond routine clinical care. Each participant will be followed for up to 18 months, or until pregnancy occurs, whichever happens first. During the study, participants will attend a total of three visits. The researchers will monitor pregnancy occurrence over a maximum of nine months after starting supplementation to assess the rate of spontaneous pregnancy. No additional procedures are required beyond usual clinical practice, making participation convenient and integrated into regular healthcare visits.

Researchers are evaluating the efficacy, safety, and tolerability of adding subcutaneous lunsekimig compared with placebo as treatment for adults aged 18 to 80 with high-risk asthma who currently do not qualify for biologic therapies. This Phase 2, randomized, double-blind, placebo-controlled study focuses on participants with mild-to-moderate asthma diagnosed for over a year, who have had at least one asthma exacerbation in the previous year. The goal is to better understand lunsekimig's effects in this specific asthma population. Participants will be randomly assigned to receive either subcutaneous injections of lunsekimig or placebo over approximately 52 weeks. Alongside this, they may continue using other asthma medications such as various inhaled treatments including fluticasone/salmeterol, budesonide/formoterol, budesonide/albuterol, or short-acting beta agonists. The study includes up to 18 visits throughout the treatment period, with some participants possibly continuing into a long-term safety (LTS) study lasting up to 60 weeks total. During the study, participants will undergo regular assessments to monitor asthma control, lung function, and the rate of asthma exacerbations. The primary measurement is the annualized rate of asthma exacerbation events from baseline up to 52 weeks. Safety and tolerability will also be closely observed. The total study duration for most participants will be around 64 weeks if they do not enter the LTS study. Researchers will gather data through clinical visits, lung function tests, and ongoing safety monitoring to evaluate the treatment's impact and participant health throughout the trial.